Advances in Patient Safety and Medical Liability

Abstract

Introduction: The Agency for Healthcare Research and Quality awarded a planning grant to Beth Israel Deaconess Medical Center, partnering with the Massachusetts Medical Society, to explore the feasibility of broadly implementing a Disclosure, Apology, and Offer (DA&O) program in Massachusetts.

Methods and Results: The study comprised 27 key stakeholder interviews that explored the perceptions of the DA&O model, the perceived barriers to implementation, and strategies for overcoming the barriers. The majority of stakeholders found the DA&O model to be the most promising strategy to improve medical liability and patient safety environments in the State, and most interviewees believed it was "the right thing to do." For each of the 12 barriers, multiple strategies were identified—based on feasibility, importance, and impact—and prioritized into a Roadmap for transforming the medical liability system in Massachusetts.

Discussion: Using the Roadmap as a guide, a statewide alliance was created to implement the Roadmap and promote the use of the DA&O model. The Massachusetts Alliance for Communication and Resolution following Medical Injury (MACRMI) was formed, and members titled their approach, Communication, Apology, and Resolution (CARe). It includes hospitals, provider organizations, patient advocacy and safety organizations, insurers, and the State bar association. A demonstration of the CARe model is underway, including a formal study to track outcomes, at six hospitals. Enabling legislation was passed, and educational materials and a resource Web site were created. MACRMI also developed algorithms, best practices, policies, and procedures and launched educational initiatives, including an annual CARe Forum, that have reached numerous stakeholder groups representing a broad variety of constituencies.

Conclusion: Data on the feasibility of the CARe model, its barriers, and strategies for overcoming those barriers were essential in understanding the challenges in implementing this model, not only in Massachusetts but nationally as well. While some of the identified barriers and strategies are unique to Massachusetts, most of the Roadmap’s components are applicable in other States.

Introduction

Massachusetts has long been a pioneer in health care reform, and this innovative spirit extends to medical liability reform. Massachusetts was the first State to adopt protections for statements of regret in December 1986,¹ and it has been an early adopter of the Disclosure, Apology, and Offer (DA&O) approach to adverse events in some health care settings.² DA&O emphasizes honesty and transparency with patients regarding adverse events and errors. Its goals are to (1) proactively identify adverse events, (2) differentiate between injuries caused by negligence and those arising from complications of disease or intrinsically high-risk medical care, (3) offer patients full disclosure and honest explanations about what went wrong and why, and (4) offer an apology and rapid, fair compensation, with patient representation, when unreasonable care caused injury. Proponents believe that DA&O is "the right thing to do," not only because it compensates patients who deserve it in a more timely manner, but also because it allows safety improvements to be made to prevent similar errors from recurring, thus protecting future patients. The primary goal of the approach is to improve safety for patients, while an added benefit is a reduction in costs and claims.

The DA&O approach to adverse events initially did not gain momentum as a risk management practice and was used sparingly in the United States in the early 2000s. Early reports from the University of Michigan Health System (UMHS)—which had implemented the approach in 2001 by fully disclosing adverse events and compensating those patients who were harmed by unreasonable care outside of the court system—were promising, but it was not until 9 years later, when UMHS published data on processes, outcomes, costs, and volume that the medical liability community began to seriously consider the approach viable. One UMHS study, published in 2010, included a before-and-after review of claims frequency, transactional costs, incidence of litigation, and time to resolution and found that all of these indicators improved with the DA&O approach.³ Other early pioneers, like Stanford University Hospital and Clinics, experienced a 38 percent reduction in overall costs over 5 years, as well as a reduction in the number of claims.⁴

In July 2010, the Agency for Healthcare Research and Quality (AHRQ) awarded Beth Israel Deaconess Medical Center (BIDMC) and their partner organization, Massachusetts Medical Society, a planning grant to determine the feasibility of widespread implementation of a DA&O program in Massachusetts and to isolate both the barriers to utilizing the approach and strategies that could overcome those barriers and allow DA&O to succeed. There had been previous suggestions of reasons for the slow adoption of this approach^5-8 but the Massachusetts study aimed to empirically investigate these issues and, if feasible, build a model that would best address impediments to DA&O. Once these challenges and strategies to overcome them were identified, the team used the suggested strategies to build a thriving, broad-based DA&O pilot program and supportive infrastructure.

Methods

The methods and results of this study have been published previously in the Milbank Quarterly.⁹ The institutional review boards of BIDMC and the Harvard School of Public Health (HSPH) reviewed and approved the project. Structured interviews were conducted with 27 respondents representing a broad range of stakeholder groups in Massachusetts who were key to implementation of the DA&O approach: the Massachusetts legislature and administration, hospital systems (including academic health centers and community hospitals), practicing physicians, liability insurers, health insurers, medical professional associations, patient advocacy organizations, malpractice attorneys, patient safety experts, major physician practice groups, and a major business association. Overall, nine of the 27 respondents were physicians.¹⁰

Using an interview guide developed by the HSPH, four main areas were covered: (1) the respondent’s institutional setting and relevant experience, (2) perceived potential for the DA&O model to improve medical liability and patient safety, (3) perceived barriers to implementing DA&O programs, and (4) suggested strategies for overcoming identified barriers.¹¹ Investigators led the interviews, which lasted 45-60 minutes.

Results

A summary of the Roadmap and the central messages of the study are provided below.10 As a result of the study, three central messages emerged:

1. There is strong support for the DA&O approach—above any other model—among respondents. The consistent view that such a model is the "right thing to do" ethically, with cost savings as an additional benefit.
2. Many proposed strategies can be pursued relatively quickly and easily.
3. The DA&O approach benefits patient safety by encouraging open discussion of error, leading to improved reporting and deeper understanding of safety risks.

The barriers and strategies collectively identified during the interviews were then shared with the project’s interviewees for individual feedback. The project team integrated stakeholder feedback into the Roadmap prior to presentation at a symposium entitled "Roadmap for Transforming Medical Liability and Improving Patient Safety in Massachusetts" (Roadmap) in March 2011. The overall Roadmap, including the barriers and strategies, was then further refined based on additional feedback from the approximately 150 symposium participants, made up primarily of physicians but also representatives of each of the other stakeholder groups.

Barriers and Strategies

The interviews revealed several barriers and potential solutions to implementation of a DA&O model. Below are the 12 most commonly cited barriers (Table 1), followed by a high-level summary of the proposed strategies for overcoming them.

In the summary of the strategies below, "Fairness to patients" and "Accountability for the process" have been combined into a single barrier "Fairness and Accountability" because the specific concerns and strategies voiced were complementary. In addition, “Opposition by insurers” was added as an additional barrier because several stakeholders observed that the current system is familiar and relatively predictable for liability insurers, whereas the impact of a change to a more proactive DA&O model cannot be predicted and thus might be opposed by this constituency.¹¹

Table 1.   Barriers to DA&O Model Implementation⁹

• Fairness and accountability: education of the public and media; legal representation for patients/families; standardized root cause analysis processes; transparent compensation formulas; and mechanisms for sharing “lessons learned” to improve patient safety.
• Physician discomfort with disclosure: physician education and training, including peer mentors; establishment of a “just culture”; support from hospital/health enterprise leadership.
• Concern about increased liability: data dissemination from sites having implemented the model.
• Physician name-based reporting: education; process change allowing institution-based reporting for adverse outcomes deemed to be system failures; and clear reporting requirements.
• Charitable immunity law: system liability through a voluntary waiver-by-settlement approach.
• Difficulty coordinating insurers: Convening a forum for insurers to cooperatively resolve codefendant issues.
• Opposition by liability insurers: data collection to better quantify the financial bottom line; education; and early involvement of liability insurers in cases where error is suspected.
• Concern that the model may not be replicable in certain settings: creation of a centralized resource center; standardized policies; education and training; and statewide risk-pooling.
• Attorneys’ interest in maintaining the status quo: education of attorneys regarding cost-effectiveness and the role of legal representation in the model; sharing of experiences by attorneys who have participated in DA&O models.
• Difficulty of getting supporting legislation passed: education of legislators; identification of key supporters among the legislators, as well as other key stakeholders such as State court judges.
• Forces of inertia: creation of resources to support leaders; identification of champions in each constituency; capitalizing on opinion leaders and patient representatives; dissemination of data on the  shortcomings of the current system; collaborative influence of key stakeholders.
• Insufficient evidence that the DA&O approach works: collection and dissemination of data from institutions that have implemented the model, including pilot programs in varied settings.

Discussion

In this study, we confirmed some of the potential barriers identified in previous commentary,^4-7 uncovered new barriers, and measured the frequency with which diverse stakeholders perceive them as problems. The study also highlighted potential solutions that stakeholders saw as feasible and important to pursue. We were able to discern that the DA&O program is the best alternative to the current dysfunctional medical liability system, and that it provides the strategies necessary to meet the challenges implementation could bring.

Following dissemination of findings from the study through a variety of media channels, stakeholders were interested in moving towards broader implementation of a DA&O approach in Massachusetts. Building on this momentum, a Roadmap to DA&O implementation was developed from this study’s recommendations as an outline for starting a DA&O program.

As recommended in the Roadmap, an alliance was formed to sustain this momentum around building DA&O models in the State: the Massachusetts Alliance for Communication and Resolution following Medical Injury (MACRMI). MACRMI currently comprises members from a variety of stakeholder groups, including six pilot hospitals, liability insurers, the Board of Registration in Medicine, the Massachusetts Bar Association, the Massachusetts Coalition for the Prevention of Medical Errors, the Massachusetts Hospital Association, the Massachusetts Medical Society, and Medically Induced Trauma Support Services. To begin, MACRMI renamed the DA&O approach to better embody its spirit and mission, calling it Communication, Apology, and Resolution (CARe).

Over a 6-month period, parallel with the launch of MACRMI, the Massachusetts Medical Society negotiated consensus legislation with the Massachusetts Bar Association and the Massachusetts Academy of Trial Attorneys for the purpose of facilitating the implementation of CARe. Passed in August 2012, this legislation established a 6-month pre-litigation notice period with shared access to all pertinent medical records, expanded the protections for apology which now include protection of statements of fault (e.g., "I am sorry that I caused your injury"), and provided guidelines for disclosure of adverse events.

In order to build on the empirical experiences of stakeholders who were interviewed through the planning grant and to understand how CARe could work in a variety of settings, MACRMI pursued implementing CARe programs through a pilot program at six institutions in Massachusetts. MACRMI developed clear policies, procedures, and algorithms for CARe programs and also created guides for facilities to implement each of these elements. Using its own tools, MACRMI facilitated the launch of pilot CARe programs in six hospitals across Massachusetts, including two academic medical centers and their four affiliated community hospitals. The sites have a variety of insurance models, including a captive model (e.g., hospitals insure themselves), a shared-captive model, and a combination of captive and commercial models. The pilot began in December 2012, when the HSPH began collecting data for a 3-year study of the effort, measuring costs, volume, and perceptions of key health care leaders. The 3‑year study period ended in December 2015, and analysis continues with publication of the data expected in Fall 2017.

MACRMI has also developed strategies to help physicians with disclosure practices and training. Several of the pilot sites implemented "just in time" communication coaching. A rapid response pager number is available 24 hours a day for clinicians to call for assistance with properly communicating an adverse event to a patient and guidance on what to expect from the patient in that conversation. Pilot sites also educated their staff about the merits of CARe programs and the steps clinicians need to take after an adverse event to make the program successful (e.g., where resources are located, how to document the disclosure in the chart).

MACRMI is also working with the National Practitioner Data Bank (NPDB) and Massachusetts Board of Registration in Medicine (BORM) to clarify reporting requirements for CARe cases so that they can better inform physicians of the implications of resolving a case through CARe. The original pilot sites continue their CARe programs. Two additional entities joined MACRMI and implemented CARe, and several more are in the implementation planning process. By the end of 2017, there will be three academic medical centers, seven community hospitals, and an outpatient multispecialty group running CARe programs in Massachusetts.

Finally, MACRMI has launched a comprehensive resource Web site (www.macrmi.info), which includes a variety of relevant articles, algorithms, policies, and tools that are freely accessible for facilities interested in starting their own CARe programs. The Web site has sections specifically geared toward patients and providers with frequently asked questions, a blog, and all of MACRMI’s resources, including a CARe brochure aimed at guiding patients through the CARe process. Resources are developed and approved by all members of MACRMI, and requests are solicited from MACRMI members and the local risk/patient safety community so that resource development directly responds to need. Resources include Best Practices for facilities and attorneys, conversation guides, algorithms, and a program implementation guide.

MACRMI also hosts an annual CARe forum. The first forum was held in April 2013. Each year, the forum brings together experts from around the country to a wide audience of risk managers, hospital administrators, physicians, and patients who are interested in making this model a reality in their institutions. Topics and panels are selected based on feedback from attendees and challenges or questions voiced from MACRMI constituents. Some topics have included physician perspectives on CARe, insurer and attorney collaboration in CARe, and a panel discussion involving all parties from a resolved CARe case. Attendees find the forums helpful in increasing their understanding of how the CARe model is different from the status quo and what elements need to be in place at their own institutions to make a successful transition to CARe. These forums will continue to be held annually to encourage the use of CARe in health care facilities throughout the region.

Conclusion

The Massachusetts study clarified the benefits of a DA&O model, the roadblocks that may be encountered in implementing such a model, and the strategies for overcoming those impediments. DA&O offers an avenue for bringing diverse stakeholders together because it presents a plausible value proposition to patients. Most stakeholders believe it is “the right thing to do,” despite its challenges. Forming a statewide alliance, such as MACRMI, has been successful in rapidly disseminating the Roadmap’s strategies and supporting pilots of DA&O in Massachusetts. We believe this model can be highly successful in other States, not only because we believe the barriers are applicable to most other settings, but because we have seen the power of a variety of organizations, some formerly at odds, working together toward a common goal that they believe will create a better health care system for all.

Acknowledgments

The initial work in planning for this project was supported by the Agency for Healthcare Research and Quality (AHRQ grant HS19537). We acknowledge and thank our sponsors who, through their generosity, have enabled us to implement the Roadmap and make the CARe program and MACRMI a reality in Massachusetts: Baystate Health Insurance Company, Blue Cross Blue Shield of Massachusetts, Coverys, CRICO RMF, Harvard Pilgrim Health Care, the Massachusetts Medical Society, Reliant, and Tufts Associated Health Plan. The statements and opinions in this paper are those of the authors and do not represent the position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

Author Affiliations

Kenneth E.F. Sands, MD, MPH, Chief Patient Safety Officer, Healthcare Corporation of America, Nashville, TN. Alan C. Woodward, MD, Chair, Committee on Professional Liability, Massachusetts Medical Society, Waltham, MA. Melinda B. Van Niel, MBA, Project Manager, Health Care Quality, Beth Israel Deaconess Medical Center, Boston, MA.

Address correspondence to: Melinda B. Van Niel, Project Manager, Patient Safety, Department of Health Care Quality, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA 02215 or email.

References

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9. Bell SK, Smulowitz PB, Woodward AC, et al. Disclosure, apology, and offer programs: stakeholders' views of barriers to and strategies for broad implementation. Milbank Q 2012; 90(4):682-705.

10. Executive Summary: A Roadmap for Transforming Medical Liability and Improving Patient Safety in Massachusetts. Grant HS 19537-01 funded by the Agency for Healthcare Research and Quality 2012. http://www.macrmi.info/resource_library/#sthash.te67sNoW.dpbs.

11. Sands K. Removing Barriers to Disclosure and Offer Models. Grant HS 19537-01 funded by the Agency for Healthcare Research and Quality 2011; 5.

Appendix: PARS Program Planning Methods and Procedures Timeline